BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MEDICAL STANDARD CO., LTD.

    Reg #: 3003941243 · FEI: 3003941243 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDICAL STANDARD CO., LTD.
    Registration Number
    3003941243
    FEI Number
    3003941243
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    701 MK Tower, 67, Jeongui-ro
    City
    Songpa-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K023460

    Owner / Operator

    Firm Name
    MEDICAL STANDARD CO., LTD.
    Operator Number
    9053371
    Address
    701 MK Tower, 67, Jeongui-ro
    City
    Songpa-gu
    State
    Seoul
    Postal Code
    05835
    Country
    KR
    Correspondent
    Hyunji Ko

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    Jung Ryun Ahn
    Address
    115 East 34th street, 13J
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    646 3576058

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    PACS

    Establishment Types

    Manufacture Medical Device